# FDA recall Z-2356-2024

> **MED-EL Elektromedizinische Gereate, Gmbh** · Class II · device recall initiated 2024-04-18.

## Product

Mi1250 SYNCHRONY 2, Item Numbers:    a) 39541, FLEXSOFT S-Vector;   b) 39545, FLEX28 S-Vector;   c) 39547, FLEX26 S-Vector;   Cochlear Implant

## Reason for recall

A small number of devices may have a higher probability of a crack within the internal electronics substrate which could result in a non-functional device.

## Distribution

US, Durham, NC

## Key facts

- **Recall number:** Z-2356-2024
- **Recalling firm:** MED-EL Elektromedizinische Gereate, Gmbh
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-04-18
- **Report date:** 2024-07-24

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Innsbruck, Austria

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2356-2024

## Citation

> AI Analytics. FDA recall Z-2356-2024. Retrieved 2026-07-12 from https://api.ai-analytics.org/recall/Z-2356-2024. Source: US FDA. Licensed CC0.

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